(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

February 28, 2010

Study Completion Date

April 30, 2010

Conditions
Ulcerative Colitis
Interventions
PROCEDURE

Blood sampling, endoscopy

Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores

DRUG

Budesonide MMX® 6 mg

6 mg/day, 6 mg tablets

DRUG

Budesonide MMX® 9 mg

9 mg/day, 9 mg tablets

DRUG

Entocort EC® 3 mg

9 mg/day, 3 mg tablets

DRUG

Placebo

Placebo

Trial Locations (71)

1002

Paula Stradina Clinical University Hospital, Riga

1006

Digestive Disease Centre Gastro, Riga

1038

Clinical University Hospital Gailezers, Riga

2046

Centre for Digestive Diseases, Sydney

3004

The Alfred Hospital, Melbourne

3168

Monash Medical Centre, Melbourne

5000

Royal Adelaide Hospital, Adelaide

5417

Daugavpils Regional Hospital, Daugavpils

10138

East Tallinn Central Hospital, Tallinn

10617

West Tallinn Central Hospital, Tallinn

11486

IBD-Unit, Sophiahemmet, Stockholm

16132

Dipartimento di Medicina Interna e Specialità Mediche (DIMI), Genova

20098

Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia, Milan

30322

East Viru Central Hospital, Kohtla-Järve

33081

CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica, Aviano

49074

Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology, Dnipro

50009

Kaunas Medical University Hospital, Kaunas

51014

Tartu University Hospital, Tartu

61018

City Clinical Emergency Hospital named after O.I.Meschaninov,, Kharkiv

65114

Odessa city Polyclinic #20, Therapeutic Dept. 6, Odesa

76231

Siauliai District Hospital, Šiauliai

79013

Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease, Lviv

94901

Gastroenterologické a Hepatologické centrum, Nitra

105203

Federal State Institution ?National Medical Surgical Center, Moscow

121309

"GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution State Clinical Hospital # 51", Moscow

123423

State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care, Moscow

127006

"GUZ of Moscow City Clinical Hospital #24", Moscow

193015

Saint-Petersburg GUZ City polyclinic #38 28, Saint Petersburg

197110

Krestovsky Ireland Medical Institute, Saint Petersburg

199004

FGU North-West DIstrict Medical Center of Roszdrav, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

400107

ZAO Clinic Dvizhenie, Volgograd

VIC 3128

Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,, Box Hill

Unknown

Imelda Hospital, Bonheiden

Hôpital Beaujon, Clichy

Hospital Saint-Louis, Paris

Yaron Niv, Petah Tikva

Centrum Leczenia Chorób Cywilizacyjnych, Warsaw

Cabinet Medical, Oradea

Spitalul Judetean Sibiu, Sibiu

Centrul de Gastroenterologie Dr. Goldis Adrian, Timișoara

St. Petersburg State Medical Academy n.a. I.I. Mechnikov, Saint Petersburg

Yaroslavl Region Clinical Hospital, Yaroslavl

NsP Nove Mesto nad Vahom n.o., Nové Mesto nad Váhom

Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital, Uzhhorod

"Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station Uzhgorod", Uzhhorod

03215

M.Marcinkeviciaus Hospital, Vilnius

08661

Vilnius University Hospital Santariskiu Klinikos, Vilnius

03-580

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warsaw

15-842

Gastromed S.C., Bialystok

Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa, Bialystok

81-572

NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw, Gdynia

NZOZ Centrum Leczenia Chorob Cywilizacyjnych, Gdynia

31-531

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,, Krakow

Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych, Krakow

90-302

Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA, Lodz

NZOZ Polimedica, Lodz

81-756

Endoskopia Sp. z o.o., Sopot

Endoskopia Sp.z o.o., Sopot

84-200

Indywidualna Specjalistyczna Praktyka Lekarska, Wejherowo

020125

Spitalul Clinic Colentina Sectia Gastroenterologie, Bucharest

813 69

FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova, Bratislava

826 06

FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska, Bratislava

416 85

Sahlgrenska Univerity Hospital, Gothenburg

221 85

Lund University Hospital, Lund

118 83

Div. of Gastroenterology and Hepatology, Stockholm

171 76

Dept. of Gastroenerology and Hepatology, Stockholm

OX3 9DU

John Radcliffe Hospital, Headington

CV2 2DX

University Hospital of Coventry and Warwickshire, Coventry

EH4 2XU

Gastrointestinal Unit, Edinburgh

HA1 3UJ

St Marks Hospital, Harrow

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cosmo Technologies Ltd

INDUSTRY

lead

Bausch Health Americas, Inc.

INDUSTRY

NCT00679380 - (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Biotech Hunter | Biotech Hunter